Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers

Eligible subjects will be allocated to one of four cohorts based on tumour type and presence of specific biomarker. Subjects will receive open-label Dacomitinib as tablets for oral administration on a continuous daily basis at a dose of 30 mg for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects with \>=G2 toxicity attributable to dacomitinib, will continue dacomitinib at 30 mg orally once daily. In subjects with \<=G1 toxicity, investigator and subjects will make a shared decision for dose escalation of dacomitinib to 45 mg orally once daily or continuation of dacomitinib at 30 mg orally once daily. Subjects will then continue on therapy until disease progression, new systemic anticancer therapy instituted, intolerable toxicities, withdrawal of consent, death, or investigator decision dictated by protocol compliance, whichever occurs first.

NCT Number	NCT04946968
Lead Sponsor	National Cancer Centre, Singapore Collaborators: Singapore Translational Cancer Consortium, Cancer Science Institute of Singapore, Genome Institute of Singapore
Conditions	Advanced Solid Tumours, Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Enrollment	24 participants
Start Date	2021-08-24
Primary Completion	2027-04 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2025-06-11